A Phase 4 interventional study of Bupivacaine and Opioid in Pain, Intractable, Breakthrough Pain and Chronic Pain, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 31 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-03-24.
Sponsored by University Hospitals Cleveland Medical Center · Phase 4, Interventional, and Treatment
The purpose of this study is to determine whether the local anesthetic bupivacaine delivered intrathecally in small doses via PTM self-administered boluses significantly improves the breakthrough pain and functional status of patients with chronic intractable pain who are managed with an intrathecal drug delivery system.
Methodology /Technical Approach:
Seventeen patients who are already using SynchroMed II pump containing an admixture of bupivacaine and an opioid and using PTM doses will receive Solution A during the first week of the study and will be crossed over to Solution B during the second week of the study. Solution A and Solution B would consist of either the patient's usual intrathecal opioid with bupivacaine at the same concentrations or the usual patient's intrathecal opioid at the same concentration but without bupivacaine. Only the Investigational Pharmacy at University Hospitals Case Medical Center (UHCMC) would be aware of the contents of Solution A and Solution B. Patients and study personnel in the Pain Medicine Division would be blinded to the solution content. The sequence of pump refills will be as follows:
Both patients and the evaluating physician will be blinded. In order to accomplish this, only the central compounding (investigational) pharmacy at UHCMC would make two solutions labeled: A or B respectively. Study subjects will be randomized and randomization order will be held at the pharmacy that will supply the medication. Patients will be kept on each solution for one week. Data will be collected daily
Primary outcome measures will include 0-10 numerical rating scale (NRS) or Visual Analogue Scale (VAS) both immediately before and within 30 minutes after a PTM bolus. Patients will be provided with a diary to record pain scores just before a PTM bolus and the lowest pain score within half an hour after a PTM bolus. Only 5 recording per day on days 3-7 and 10-14 will be available on the diary-thus patients would record pain scores only before and after the first 5 PTM boluses. Only the scores before and after the first 3 successful PTM boluses would be considered. Successful PTM activations would be determined by review of the patient PTM diary and the internal log from the intrathecal drug delivery system. Each recording on the PTM diary would be time matched to the successful PTM activation code in the internal log. This will obviate any potential mis-administered bolus whereby the patient does not activate the bolus device appropriately. Secondary outcome measures will include average NRS pain scores for the week, functional capacity as evaluated by the Oswestry disability index (ODI) scores, Global Impression of Change and painDETECT. Other relevant data such as number of boluses used and paresthetic sensation post bolus (if felt)/patient guess of blinding arm would be recorded.
90 studies on the registry are indexed under Pain, Intractable; 16 are open to participants now.
This study's enrollment of 17 is below the median of 60 across 64 interventional studies indexed under Pain, Intractable.
Browse Pain, Intractable studies →University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
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Exclusion Criteria
Intrathecal solution has bupivacaine with an opioid (hydromorphone, fentanyl or morphine). Patients will administer PTM bolus of bupivacaine with opioid. The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be \>2 and \<10. The bupivacaine dosage would range between 0.4 and 1.5 mg per bolus. The opioid dose will vary depending on the concentration of the opioid in the solution.
Drug: Bupivacaine · Drug: Opioid
Intrathecal solution has only an opioid (hydromorphone, fentanyl or morphine) and no bupivacaine. Patients will administer PTM bolus of opioid without bupivacaine. This opioid bolus dose would be the same as they would have received prior to enrolling in the study (with bupivacaine). The bolus will be administered over 2 minutes and will have a variable frequency depending on patient's need but the number of boluses should be \>2 and \<10.
Drug: Opioid
Patient-activated intrathecal bolus for incident pain
Patient-activated intrathecal bolus for incident pain
Also known as: Fentanyl, Hydromorphone, Morphine
Change From Baseline in the Numerical Rating Pain Scale (NRS)
Patients will be provided with a diary to record pain scores just before a PTM bolus and the lowest pain score within half an hour after a PTM bolus. Numerical Rating Pain Scale (NRS): scale from 0-10 0 = no pain 10 = worst imaginable pain
Time frame: Before self-administered bolus using Patient Therapy Manager device (PTM) and within 30 minutes of PTM bolus
Change From Baseline in Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI): calculated as a percentage based on scores from 0-5 in 10 categories (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, travelling). 0 signifies no pain interference while 5 signifies maximum possible pain interference in the 10 categories. Scores from 0-5 for 10 categories are added and divided by total possible score (50) X 100 to give percentage. Interpretation of percentage scores: 0 - 20% minimal disability 21-40% moderate disability 41-60% severe disability 61-80% crippled 81-100% either bed bound or patient is exaggerating symptoms
Time frame: Day 0, 7, 14, score at day 7 or day 14 reported
Change From Baseline in Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC): reflects patient's belief about the efficacy of treatment 1. = very much improved 2. = much improved 3. = minimally improved 4. = no change 5. = worse 6. = much worse 7. = very much worse
Time frame: Day 0, 7, 14, score at day 7 or day 14 reported
Change From Baseline in painDETECT
painDETECT is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain. A total score that ranges from -1 to 38 can be calculated from the nine items, with higher scores indicating higher levels of pain.
Time frame: Day 0, 7, 14, score at day 7 or day 14 reported
Change From Baseline in Average Weekly Numeric Pain Rating Score (NRS)
Average Weekly Numeric Pain Rating Score (NRS) over the past week Numerical Rating Pain Scale (NRS): scale from 0-10 0 = no pain 10 = worst imaginable pain
Time frame: Day 0, 7, 14, score at day 7 or day 14 reported
Change From Baseline in Treatment Satisfaction
A 5-point qualitative Likert scale was used to report measures of patient satisfaction (i.e., not satisfied at all, not satisfied, somewhat, satisfied, very satisfied). To quantify satisfaction, these responses were transformed to a scale of 0-4, with higher numbers representing greater levels of satisfaction.
Time frame: Day 0, 7, 14, score at day 7 or day 14 reported
| Milestone | Bupivacaine + Opioid First, Then Opioid | Opioid First, Then Bupivacaine + Opioid |
|---|---|---|
| Started | 8 | 9 |
| Completed | 8 | 8 |
| Not completed | 0 | 1 |
| Withdrew: Pump motor stall | 0 | 1 |
Patients will be provided with a diary to record pain scores just before a PTM bolus and the lowest pain score within half an hour after a PTM bolus. Numerical Rating Pain Scale (NRS): scale from 0-10 0 = no pain 10 = worst imaginable pain
| units on a scale | Bupivacaine + Opioid | Opioid |
|---|---|---|
| Change From Baseline in the Numerical Rating Pain Scale (NRS) | 1.87 ± 1.4 | 1.81 ± 1.47 |
Oswestry Disability Index (ODI): calculated as a percentage based on scores from 0-5 in 10 categories (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, travelling). 0 signifies no pain interference while 5 signifies maximum possible pain interference in the 10 categories. Scores from 0-5 for 10 categories are added and divided by total possible score (50) X 100 to give percentage. Interpretation of percentage scores: 0 - 20% minimal disability 21-40% moderate disability 41-60% severe disability 61-80% crippled 81-100% either bed bound or patient is exaggerating symptoms
| units on a scale | Bupivacaine + Opioid | Opioid |
|---|---|---|
| Change From Baseline in Oswestry Disability Index (ODI) | .88 ± 9.4 | 2.67 ± 9.02 |
Patient Global Impression of Change (PGIC): reflects patient's belief about the efficacy of treatment 1. = very much improved 2. = much improved 3. = minimally improved 4. = no change 5. = worse 6. = much worse 7. = very much worse
| units on a scale | Bupivacaine + Opioid | Opioid |
|---|---|---|
| Change From Baseline in Patient Global Impression of Change (PGIC) | -0.06 ± 2.11 | 1.25 ± 1.81 |
painDETECT is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain. A total score that ranges from -1 to 38 can be calculated from the nine items, with higher scores indicating higher levels of pain.
| units on a scale | Bupivacaine + Opioid | Opioid |
|---|---|---|
| Change From Baseline in painDETECT | 0.69 ± 2.96 | 0.25 ± 4.75 |
Average Weekly Numeric Pain Rating Score (NRS) over the past week Numerical Rating Pain Scale (NRS): scale from 0-10 0 = no pain 10 = worst imaginable pain
| units on a scale | Bupivacaine + Opioid | Opioid |
|---|---|---|
| Change From Baseline in Average Weekly Numeric Pain Rating Score (NRS) | -0.47 ± 1.59 | -0.38 ± 1.69 |
A 5-point qualitative Likert scale was used to report measures of patient satisfaction (i.e., not satisfied at all, not satisfied, somewhat, satisfied, very satisfied). To quantify satisfaction, these responses were transformed to a scale of 0-4, with higher numbers representing greater levels of satisfaction.
| units on a scale | Bupivacaine + Opioid | Opioid |
|---|---|---|
| Change From Baseline in Treatment Satisfaction | 2.36 ± 1.22 | 1.94 ± 1.18 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bupivacaine + Opioid | 0/16 (0%) | 0/16 (0%) | 3/16 (18.8%) |
| Opioid | 0/16 (0%) | 0/16 (0%) | 3/16 (18.8%) |
| Event | Bupivacaine + Opioid | Opioid |
|---|---|---|
| headacheNervous system disorders | 3/16 | 1/16 |
| numbness/tinglingNervous system disorders | 1/16 | 2/16 |
| nauseaNervous system disorders | 2/16 | 1/16 |
| fatigueGeneral disorders | 0/16 | 1/16 |
| anxietyPsychiatric disorders | 0/16 | 1/16 |
| skin irritationSkin and subcutaneous tissue disorders | 0/16 | 1/16 |
| urinary hesitancyRenal and urinary disorders | 0/16 | 1/16 |
Participants who finished study.
| Age, Categorical(Participants) | Bupivacaine + Opioid | Opioid | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 4 | 8 |
| >=65 years | 4 | 4 | 8 |
| Age, Continuous(years) | Bupivacaine + Opioid | Opioid | Total |
|---|---|---|---|
| Mean | 63.125 ± 8.96 | 63.75 ± 10.8 | 63.43 ± 9.93 |
| Sex: Female, Male(Participants) | Bupivacaine + Opioid | Opioid | Total |
|---|---|---|---|
| Female | 5 | 6 | 11 |
| Male | 3 | 2 | 5 |
| Race (NIH/OMB)(Participants) | Bupivacaine + Opioid | Opioid | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 7 | 8 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Bupivacaine + Opioid | Opioid | Total |
|---|---|---|---|
| United States | 8 | 8 | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of May 2016, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2022, 4 years 3 months after primary completion.
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Studies of the drug tested here: Bupivacaine
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